Clinical Trial

Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients

Study acronym: Nerivio
Not Yet Recruiting
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Summary
The goal of this trial is to learn how the Nerivio® device works to treat Amplified Musculoskeletal Pain Syndrome (AMPS) in children ages 8-18. Nerivio® is a wearable device that activates specific nerves in the upper arm. This causes a response from the brain that has been helpful for people who experience migrane headaches. The main questions this study aims to answer are: * How well does the Nerivio® device help in reducing pain in children with AMPS? * Does the use of the Nerivio® device help improve quality of life in children with AMPS? * How satisfied are children and their families with the use of the Nerivio® device for treatment of AMPS? Researchers will compare the use of the Nerivio® device with usual treatment for AMPS (including pain medications, physical therapy, and other interventions) to see how well the Nerivio® device helps control pain. Participants will be in one of two groups, decided by: * Those who are in the "control" group will use their usual practices to control pain. * Those who are in the "intervention" group will use the Nerivio® device once every other day. All participants in the "control group" will: * Complete surveys and answer questions about their pain and how it affects their daily life * Use their existing methods for pain control. All participants in the "intervention" group will: * Complete surveys and answer questions about their pain and how it affects their daily life * Learn how to work the Nerivio® device and smartphone app. * Use the Nerivio® device every other day (every 48 hours).
Trial Details
NCT Number NCT07249931
Lead Sponsor Children's Health
Collaborators: Theranica
Conditions Amplified Musculoskeletal Pain Syndrome (AMPS)
Enrollment 40 participants
Start Date 2025-12-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-25